ThermaCare HeatWraps ThermaCare HeatWraps - Menstrual (UDI 00305733020029)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00305733020029), received between Dec 31, 2018 and Oct 13, 2022 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A 26-YEAR-OLD FEMALE WHO USED A THERMACARE MENSTRUAL 8HR HEAT WRAP. THE CONSUMER WAS HEALTH AND DID NOT SMOKE. THE CONSUMER WAS ALLERGIC TO SULFONAMIDES. CONCOMITANT PRODUCTS INCLUDED A MULTIVITAMIN. ON (B)(6) 2022, THE CONSUMER USED A THERMACARE MENSTRUAL 8HR HEAT WRAP APPLIED AGAINST HER UNDERWEAR AND THEN ATTACHED IT TO WEAR AROUND HER ABDOMEN. ON (B)(6) 2022, AFTER FOUR TO FIVE HOURS OF WEARING THE HEAT WRAP AND WHEN SHE CAME BACK FROM WORK, SHE EXPERIENCED ITCHING ON HER SKIN UNDERNEATH THE PATCH. WHILE SHE ITCHED, SHE REALIZED THAT HER SKIN WAS COMING UP. SHE REMOVED THE WRAP AND EXAMINED HER SKIN. SHE NOTED BLISTERS ON HER SKIN WHERE THE WRAP WAS TOUCHING. THE SKIN LOOKED BURNED TO HER. SHE NOTED SHE HAD SECOND DEGREE BURNS ON HER PUBIC AREA. SHE HAD BEEN KEEPING THE AREA CLEAN BUT HAD NOT SOUGHT MEDICAL CARE OR PERFORMED ANY OTHER THERAPIES. SHE NOTED SHE DID NOT HAVE ANY BROKEN SKIN PRIOR TO WEARING THE HEAT WRAP AND DID NOT USE ANY CREAMS OR OINTMENTS PRIOR TO SUING THE HEAT WRAP. WHEN SHE FELT ITCHING, SHE WENT TO SCRATCH THE SKIN AND IT STARTED PEELING OFF. AS OF (B)(6) 2022

  Patient problems: Itching Sensation; Partial thickness (Second Degree) Burn; Peeling

  MAUDE report 15601057 ↗
• InjurySep 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 02-SEP-2022 A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A FEMALE IN HER 30'S WHO USED A THERMACARE MENSTRUAL 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED ASTHMA ATTACKS AND PRIOR USE OF THERMACARE WITHOUT INCIDENT FOR YEARS. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE IN (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE MENSTRUAL HEAT WRAP. ON AN UNSPECIFIED DATE IN (B)(6) 2022, THE CONSUMER EXPERIENCED A BLISTER BURN. ONE CELL INSIDE THE WRAP BECAME HOTTER THAN THE OTHERS AND SHE DEVELOPED A BURN AFTER APPLYING IT. THE CONSUMER WAS NOTED TO HAVE USED THE HEAT WRAP CORRECTLY AND WITHOUT A HEATING PAD. THE CONSUMER'S MOTHER WAS A NURSE WHO TREATED HER SYMPTOMS WITH ANTIBIOTIC OINTMENT AND APPLIED HONEY IN BETWEEN APPLICATIONS OF THE ANTIBIOTIC OINTMENT. ON (B)(6) 2022, THE CONSUMER'S BLISTER POPPED AND WAS PURPLE IN COLOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn; Skin Discoloration

  MAUDE report 15458866 ↗
• InjuryJul 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 29-JUN-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA TELEPHONE REGARDING A 33-YEAR-OLD FEMALE WHO USED THERMACARE MENSTRUAL 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED PRIOR USE OF A HEAT WRAP WITHOUT EVENT. CONCOMITANT PRODUCTS INCLUDED MUCINEX (GUAIFENESIN). ON (B)(6) 2022, THE CONSUMER TOPICALLY APPLIED A THERMACARE HEAT WRAPS MENSTRUAL PAIN THERAPY ON THE MIDDLE OF THE STOMACH BELOW THE BELLY BUTTON FOR AN UNSPECIFIED INDICATION. AFTER TAKING THE DEVICE OFF AFTER 7 HOURS, SHE TOOK THE HEAT WRAP OFF AND NOTICED THAT SHE HAD RED AREAS LIKE A BURN ON THE LEFT SIDE OF HER PELVIC REGION. A BLISTER HAD FORMED IN THE AREA. FOR TREATMENT SHE COVERED THE AREA WITH A BAND AID. SHE DID NOT SEEK ANY MEDICAL ATTENTION FOR HER SYMPTOMS. THE CONSUMER WAS WATCHING THE AREA CLOSELY. THE CONSUMER NOTED IF SHE STILL HAD A BLISTER BY THE END OF THE WEEK OF (B)(6) 2022, SHE WOULD SEEK MEDICAL ATTENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15016113 ↗
• InjuryApr 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 24-MAR-2022, A SPONTANEOUS REPORT FROM THE UNITED STATES WAS RECEIVED VIA EMAIL FROM A CONSUMER REGARDING A FEMALE (AGE NOT PROVIDED) CONSUMER WHO USED A THERMACARE MENSTRUAL 8HR HEAT WRAP. MEDICAL HISTORY INCLUDED UNSPECIFIED PAINS. CONCOMITANT PRODUCTS WERE NOT PROVIDED. ON AN UNSPECIFIED DATE, THE CONSUMER TOPICALLY APPLIED A THERMACARE MENSTRUAL 8HR HEAT WRAP (LOT NUMBER AND EXPIRATION DATE NOT PROVIDED) FOR PAIN. ON AN UNSPECIFIED DATE AND AN UNSPECIFIED TIME AFTER THE CONSUMER APPLIED THE HEAT WRAP, SHE EXPERIENCED A SECOND-DEGREE BURN (NOT MEDICALLY CONFIRMED). SHE HAD TO MISS WORK. DUE TO THE LOCATION OF THE BURN, SHE COULD NOT WEAR CLOTHING. SHE NOTED THAT SHE HAD HOSPITAL BILLS BECAUSE OF THE EVENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 14106404 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT VERBATIM [PREFERRED TERM] LARGE RED BURNS FROM WHERE THE PRODUCT WAS ON HER STOMACH [APPLICATION SITE BURN], INFLAMED [APPLICATION SITE INFLAMMATION], , NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS (B)(6) FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL, LOT NUMBER CW9498 AND EXPIRY DATE DEC2022, UPC NUMBER: 305733020029, LOT NUMBER AW2098 AND EXPIRY DATE APR2022) FROM (B)(6) 2020 TO (B)(6) 2020 AT UNKNOWN DOSE FOR REAL BAD MENSTRUAL CRAMPS. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. ON (B)(6) 2020, THE PATIENT NOTICED SHE HAD LARGE RED BURNS FROM WHERE THE PRODUCT WAS ON HER STOMACH. PATIENT USED 3 WRAPS AND SHE NOTICED, SHE JUST FINISHED HER CYCLE AND SHE NOTICED SHE HAD LARGE RED BURNS FROM WHERE THE PRODUCT WAS ON HER STOMACH. SO IT WAS LIKE AT THE BOTTOM OF HER STOMACH AND THE TOP OF HER WOMAN AREA. SHE HAD BAD BURNS FROM WHERE THE CELLS WERE, SO ON THE PRODUCT THERE WERE 8 DIFFERENT POUCHES THAT HAD THE IRON IN THEM OR WHATEVER AND SHE HAD 8 DIFFERENT BURNS FROM EACH OF THE 8 CELLS. SHE SAID THIS WAS HER FIRST TIME USING THIS PRODUCT AND SHE HAD REDNESS SHAPED LIKE THE HEAT CELLS. THERE WERE 8 C

  Patient problems: Burn, Thermal; Erythema; Inflammation; Irritation

  MAUDE report 10529281 ↗
• InjuryDec 19, 2019Loss of or Failure to Bond

  RED MARK/SHE ALWAYS GET REDNESS WHERE SHE PUTS IT, BECAUSE IT'S HOT [ERYTHEMA], BECAUSE IT'S HOT [DEVICE ISSUE], DID NOT STICK [DEVICE ADHESION ISSUE]. CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS FEMALE CONSUMER OF UNKNOWN AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) LOT NUMBER T26691; W87447; W3362, UDI NUMBER: (B)(4), FROM UNKNOWN DATE FOR UNKNOWN INDICATION. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. CONSUMER HAD 4 BOXES OF THE THERMACARE MENSTRUAL HEATWRAPS AND THEY WERE RECALLED. SHE USED ONE AND IT DID NOT STICK AND LEFT A RED MARK THAT LASTED 2 DAYS. CONSUMER USED THE THERMACARE MENSTRUAL HEAT WRAPS, THE EIGHT HOUR ONES, AND SHE READ THAT THERE WAS A RECALL, AND SHE HAD FOUR BOXES AT HOME. SHE BOUGHT THEM LAST MONTH, AND USED TWO OUT OF THREE FROM THE FIRST BOX. SHE ALWAYS GOT REDNESS WHERE SHE PUT IT, BECAUSE IT'S HOT, BUT SHE'S NOT HAD A REACTION OR ANYTHING. THE ACTION TAKEN IN RESPONSE TO THE EVENT OF THE PRODUCT WAS UNKNOWN. THE EVENT OUTCOME WAS RESOLVED. ACCORDING TO INVESTIGATIONS RESULTS FROM PRODUCT QUALITY COMPLAINTS (PQC) GROUP, LOT NUMBER W3362 INVALID. INITIAL COMPLAINT ASSESSMENT: AN E

  Patient problems: Erythema

  MAUDE report 9492199 ↗
• MalfunctionOct 31, 2019Unintended Ejection

  EVENT VERBATIM [PREFERRED TERM] IT LOOKED LIKE THE CONTENTS WERE OUT OF THE LITTLE OVAL HEAT CELL /THE CONTENTS OF THE HEAT CELLS WERE CONTAINED WITH THE WRAP AND NOT ON THE OUTSIDE [DEVICE LEAKAGE] , . CASE NARRATIVE: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. THIS FEMALE CONSUMER OF UNKNOWN AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) LOT NUMBER T78909, EXPIRATION DATE NOV2020, UDI NUMBER (B)(4), VIA AN UNSPECIFIED ROUTE OF ADMINISTRATION FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT UNKNOWN DOSE FOR AN UNSPECIFIED INDICATION. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE PATIENT THOUGHT THERE WAS A PROBLEM WITH THE THERMACARE MENSTRUAL HEATWRAPS SHE PURCHASED. SHE REPORTED THAT IT LOOKED LIKE THE CONTENTS WERE OUT OF THE LITTLE OVAL HEAT CELL. AS OF (B)(6)2018, SHE STATED THAT WHEN SHE OPENED THE FOIL POUCH SHE NOTICED THE CONTENTS OF THE HEAT CELLS WERE NOT IN THE FABRIC BUT WERE LOOSE IN THE POUCH (PENDING CLARIFICATION). AS OF (B)(6) 2018, SHE FURTHER STATED WHEN SHE OPENED THE POUCH THE CONTENTS OF THE HEAT CELLS WERE CONTAINED WITH THE WRAP AND NOT ON THE OUTSIDE. SHE NEVER WORE THE HEAT WRAP. THE ACTION TAKEN IN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9260659 ↗
• InjuryApr 18, 2019Adverse Event Without Identified Device or Use Problem

  EVENT VERBATIM [PREFERRED TERM] FOUR TO FIVE CIRCULAR BURN PLACES ON HER STOMACH/CALLER WAS BURNED THROUGH FIRST LAYER TO SECOND LAYER OF SKIN [THERMAL BURN] , THEY ARE STARTING TO SCAB BUT ARE PAINFUL [SCAB] , HER WHOLE FIRST LAYER OF SKIN WAS BURNED OFF [SKIN EXFOLIATION] , THE SCAB COMES OFF AND STARTS TO BLEED [SKIN HAEMORRHAGE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A 38-YEAR-OLD (NO PREGNANT, NO POST-MENOPAUSAL) FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), DEVICE LOT NUMBER AF0351, EXPIRATION DATE SEP2021, UDI NUMBER(B)(4), ON (B)(6) 2019 AT 1 PATCH PLACED IN UNDERWEAR FOR 3-4 HOURS FOR MENSTRUAL CRAMPS. MEDICAL HISTORY INCLUDED CROHN'S DISEASE AND SHE DID NOT HAVE TO GO TO THE PHYSICIAN RIGHT NOW BECAUSE SHE WAS IN REMISSION. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT PREVIOUSLY TOOK THERMACARE HEATWRAP (THERMACARE MENSTRUAL) SINCE SHE WAS ABOUT 14 YEARS OLD AND DID NOT EXPERIENCE ANY ADVERSE EVENT. THE PATIENT BOUGHT THERMACARE PATCHES THAT SHE PUT IN HER UNDERWEAR FOR MENSTRUAL CRAMPS. SHE GOT 4-5 BURN PLACES ON HER STOMACH ON 29MAR2019. SHE HAD USED THE PRODUCT FOR YEARS AND NEVER HAD AN ISSUE.

  Patient problems: Burn, Thermal; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 8528772 ↗
• InjuryApr 15, 2019Adverse Event Without Identified Device or Use Problem

  EVENT VERBATIM [PREFERRED TERM] PRODUCT ENDED UP GIVING HER BLISTERS, ALL ON TOP OF HER ABOUT 6, 7 OR 8 BLISTERS/THE BLISTERS HAS WORSENED & POPPED/SHE'S IN A LOT OF PAIN [BLISTER RUPTURE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER REPORTED FOR HERSELF. A FEMALE PATIENT OF AN UNSPECIFIED AGE STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), DEVICE LOT NUMBER AL8679, EXPIRATION DATE DEC2021, UDI NUMBER (B)(4), FROM AN UNSPECIFIED DATE TO AN UNSPECIFIED DATE AT UNKNOWN FREQUENCY FOR MENSTRUAL, TIME OF THE MONTH. MEDICAL HISTORY WAS NONE. THERE WERE NO CONCOMITANT MEDICATIONS. THE PATIENT REPORTED ON THERMACARE MENSTRUAL HEATWRAPS. THE PATIENT STATED PRODUCT ENDED UP GIVING HER BLISTERS ON TOP OF HER ABOUT 6, 7 OR 8 BLISTERS ON (B)(6) 2019. SHE REMARKED IT SHOCKED HER BECAUSE SHE HAD ALWAYS USED THE PRODUCT BEFORE, BUT THIS PARTICULAR ONE GAVE HER THIS REACTION OF BLISTERS, SHE HAD NEVER HAD A REACTION BEFORE. SHE STATED PRODUCT HAD BEEN WORKING REALLY GOOD FOR HER BEFORE, DURING HER MONTHLY WHILE SHE'S AT WORK BUT SHE WON'T USE THE PRODUCTS NOW. SHE STATED THE BLISTERS HAD WORSENED & POPPED. SHE REMARKED SHE'S IN A LOT OF PAIN, SHE'S GOIN

  Patient problems: Pain; Swelling

  MAUDE report 8514768 ↗
• MalfunctionApr 12, 2019Break; Leak/Splash; Nonstandard Device

  EVENT VERBATIM [PREFERRED TERM] STUFF THAT HEATS UP IS INSIDE THERE, IT FALLS OUT LIKE CHARCOAL, IT FALLS OUT LIKE IT IS COFFEE OR SOMETHING IT IS SOMETHING, YOU CANNOT WEAR THEM BECAUSE IT IS BROKEN [DEVICE LEAKAGE] , USING THERMACARE HEATWRAPS ADVANCED MENSTRUAL PAIN THERAPY FOR NECK PAIN [DEVICE USE ISSUE] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. A (B)(6)-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL) (DEVICE LOT NUMBER T26691, EXPIRATION DATE JUL2020) FROM (B)(6) 2018 (A WEEK BEFORE THE INITIAL REPORT) AT AN UNSPECIFIED FREQUENCY FOR NECK PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED PAIN. CONCOMITANT MEDICATION INCLUDED PARACETAMOL ((B)(6), STRENGTH 500MG TABLET) AT 500MG, USED OCCASIONALLY, NOT LIKE EVERYDAY FOR PAIN. THE PATIENT USED THERMACARE HEATWRAPS ADVANCED MENSTRUAL PAIN THERAPY FOR NECK PAIN. THE PATIENT STATED, "2 OUT OF 3 IN THIS BOX, THE PRODUCT ITSELF WAS NOT SEALED FOR WHATEVER THAT STUFF THAT HEATS UP IS INSIDE THERE, IT FALLS OUT LIKE CHARCOAL, IT FALLS OUT LIKE IT IS COFFEE OR SOMETHING IT IS SOMETHING, YOU CANNOT WEAR THEM BECAUSE IT IS BROKEN." THE SAMPLE HAD BEEN DISCARDED AND NO PHO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8511181 ↗
• InjuryDec 31, 2018Patient-Device Incompatibility

  EVENT VERBATIM [PREFERRED TERM] A BLISTER THAT POPPED [BLISTER] , RAISED REDNESS IN THE PATTERN OF THE HEATWRAP [ERYTHEMA] , SHE FELT A BAD STINGING [PAIN] , . CASE NARRATIVE:THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER (PATIENT). A 44-YEAR-OLD FEMALE PATIENT STARTED TO RECEIVE THERMACARE HEATWRAP (THERMACARE MENSTRUAL), DEVICE LOT NUMBER W36662, EXPIRATION DATE 30APR2021, UDI NUMBER: (B)(4), ON (B)(6) 2018 OR (B)(6) 2018 USED IN 1 DAY FOR 7 HOURS APPROXIMATELY (8AM UNTIL 3PM) FOR MENSTRUAL CRAMPS. THE PATIENT MEDICAL HISTORY INCLUDED MENSTRUAL CRAMPS. CONCOMITANT MEDICATION INCLUDED IBUPROFEN, PARACETAMOL (MIDOL) STRENGTH 500MG, 2 TABLETS DAILY FOR MENSTRUAL CRAMPS. THE PATIENT HAD USED THERMACARE HEATWRAPS ABOUT 10 YEARS AND DID NOT EXPERIENCE THE SAME PROBLEM/SYMPTOM BELOW. THE PATIENT PREVIOUSLY USED OTHER HEAT PRODUCTS FOR PAIN RELIEF (ELECTRIC HEATING PAD, HOT WATER BOTTLE, MICROWAVE GEL PACK) AND DID NOT EXPERIENCE A PROBLEM/SYMPTOM. SHE USED THE PRODUCT WHEN SHE GOT UP AROUND 8AM AND WAS WEARING LEGGINGS AND A TEE SHIRT. SHE WORKED FROM HOME. AROUND 3PM SHE FELT A BAD STINGING AND WENT TO THE BATHROOM TO CHECK UNDER THE HEATWRAP. SHE EXPERIENCED RAISED REDNESS I

  Patient problems: Cramp(s); Erythema; Pain

  MAUDE report 8206591 ↗